Most Drug Ads Did Not Follow FDA Guidelines
Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its ‘Bad Ad’ program, which the agency recently maintained is having a positive effect. But just how bad were pharmaceutical ads before the FDA launched this program? To gain some clarity, researchers examined 192 pharmaceutical ads that […]
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Former Employee Cripples Shionogi Computers
Last year, Jason Cornish resigned from his information tech job at Shionogi offices in Georgia after a dispute with a senior manager. However, he was subsequently retained as a consultant at the urging of another employee, who happened to be a long-standing friend. But last September, he again resigned. And then his friend was laid […]
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Antibacterial Chemical Raises Safety Issues
The maker of Dial Complete hand soap says that it kills more germs than any other brand. But is it safe? That question has federal regulators, consumer advocates and soap manufacturers locked in a battle over the active ingredient in Dial Complete and many other antibacterial soaps, a chemical known as triclosan. The Food and […]
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FDA Approves ‘Revolutionary’ Melanoma Treatment
FDA Wednesday approved drug, Zelboraf, for the first-line treatment of both metastatic and unresectable melanomas, reportedly the most dangerous type of skin cancer. “This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of […]
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CEL-SCI gets FDA warning letter about web site statements on Multikine
US drug developer CEL-SCI Corp (NYSE AMEX: CVM) says it received a warning letter received from the Division of Drug Advertising Marketing and Compliance (DDMAC) of the US Food and Drug Administration earlier this month regarding certain statements made about the company’s investigational therapy Multikine (leukocyte Interleukin, Injection) on its corporate web site and has […]
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Paladin Labs CEO in serious accident
Paladin Labs Inc.’s chief executive officer has been seriously injured in a cycling accident, raising uncertainty about the company at a crucial time in its history. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls Its shares fell 6% to $38.50 in afternoon trading on the […]
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Merck vaccines contaminated with plastic, says FDA
Vaccines made by Merck & Co at its West Point facility in Philadelphia, US, have been found to be contaminated with pieces of plastic on a dozen occasions since the end of 2009, according to the US FDA. Inspections have shown that pieces of plastic shrink wrap have been discovered in a number of Merck’s […]
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Tobacco giants suing FDA over warning labels mandate
Five tobacco companies, including some of the largest in the United States, filed a lawsuit against the federal government on Tuesday, alleging that government-mandated graphic warning labels on cigarette packages unconstitutionally infringe on the companies’ rights. “The primary complaint is that we think it violates the First Amendment for the government to require people who […]
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Cetero slams FDA on data falsification charge
Early-phase contract research organisation (CRO) Cetero Research has hit back at FDA for representing as pervasive misconduct what Cetero insists was an isolated incident of data falsification at its bioanalytical laboratory in Houston, Texas. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls The US-based CRO […]
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Top Ten Warning Letter Observations about the Pharmaceutical Quality Unit
The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly review Warning Letters on the FDA […]
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